Multiple clinical trials spanning Phase I through Phase III evaluate tasquinimod across several oncological and hematological indications, predominantly metastatic castration-resistant prostate cancer, alongside multiple myeloma, myelofibrosis, hepatocellular carcinoma, renal cell carcinoma, ovarian cancer, and gastric cancer. Sponsored by pharmaceutical companies such as Active Biotech AB and Ipsen alongside academic institutions like Johns Hopkins University, these studies exhibit varying statuses. Although historical trials in prostate cancer and multiple myeloma have been completed, terminated, or withdrawn, several clinical trials are currently recruiting patients to evaluate its efficacy in myelofibrosis.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06327100 | RECRUITING | Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-Essential Thrombocytosis Myelofibrosis |
M.D. Anderson Cancer Center |
2024-08-01 | PHASE1; PHASE2 |
| NCT06605586 | RECRUITING | Myelofibrosis |
Stichting Hemato-Oncologie voor Volwassenen Nederland |
2025-02-20 | PHASE1; PHASE2 |
| NCT04405167 | TERMINATED | Multiple Myeloma |
University of Pennsylvania |
2020-07-10 | PHASE1 |
| NCT02396368 | WITHDRAWN | Prostate Cancer; Bone-only Metastatic Castration-Resistant Prostate Cancer (CRPC) |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2015-03 | PHASE1 |
| NCT02159950 | COMPLETED | Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer |
Roswell Park Cancer Institute |
2015-01 | PHASE2 |
| NCT01513733 | COMPLETED | Prostate Cancer |
Andrew J. Armstrong, MD |
2012-01 | PHASE1 |
| NCT02057666 | TERMINATED | Prostatic Neoplasms, Castration-Resistant |
Ipsen |
2014-01 | PHASE3 |
| NCT02396368 | Withdrawn | Prostate Cancer|Bone-only Metastatic Castration-Resistant Prostate Cancer (CRPC) |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2015-03 | Phase 1 |
| NCT01732549 | TERMINATED | Metastatic Castrate Resistant Prostate Cancer |
Ipsen |
2013-01 | PHASE2 |
| NCT01234311 | COMPLETED | Prostate Cancer |
Active Biotech AB |
2011-03 | PHASE3 |
| NCT01743469 | COMPLETED | Advanced or Metastatic Hepatocellular Cancer; Advanced or Metastatic Ovarian Cancer; Metastatic Renal Cell Cancer; Advanced or Metastatic Gastric Carcinoma |
Ipsen |
2012-12 | PHASE2 |
| NCT02057666 | Terminated | Prostatic Neoplasms Castration-Resistant |
Ipsen |
2014-01 | Phase 3 |
| NCT01732549 | Terminated | Metastatic Castrate Resistant Prostate Cancer |
Ipsen |
2013-01 | Phase 2 |
| NCT01234311 | Completed | Prostate Cancer |
Active Biotech AB |
2011-03 | Phase 3 |
| NCT00560482 | COMPLETED | Prostate Cancer |
Active Biotech AB |
2007-12 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-05-26)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).